A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-21

Study Completion Date

2013-07-23

Brief Summary

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This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

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Detailed Description

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This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teduglutide

0.05 mg/kg/day

Group Type EXPERIMENTAL

Teduglutide

Intervention Type DRUG

0.05 mg/kg/day subcutaneously taken once per day for 12 months

Interventions

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Teduglutide

0.05 mg/kg/day subcutaneously taken once per day for 12 months

Intervention Type DRUG

Other Intervention Names

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Gattex

Eligibility Criteria

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Inclusion Criteria

* At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:

1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed